MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 2100-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number 650369SV4

Device Problems Component Falling (1105); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information not applicable.No report of patient involvement.Operator of device not applicable.Room was not in use and no one was in the room.(b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that the mavig monitor suspension fell.The room was not in use and no one was in the room when the boom fell.

Manufacturer Narrative

Ge healthcare investigation has been completed.The issue occurred at the fixation between flange (area around the screw hole where the screw's head sits) and bearing of spring arm.There was a deformation of the flange drill hole material that holds up the entire monitor suspension.The suspension supporting the monitors is designed and manufactured by (b)(4).Ge healthcare notified (b)(4) about this issue on october 23, 2015.(b)(4) investigation concluded that the flange drill holes were drilled too deep during production at a (b)(4) sub-supplier.The measured thickness of flange of the affected device was between 0.5 mm to 1.0 mm in all holes, instead of a minimum of 3 mm per specifications.It was determined that this part was manufactured with non-numeric drill machining with manual adjustment setup between 2005 and 2008.In 2008 the manufacturer changed to numeric machining with a control plan for each batch including measurement of the thickness dimension.This site will be corrected by the replacement of the monitor suspension.A field action was initiated to correct all the impacted sites (report number 9611343-12/30/15-003-c, ge healthcare reference fmi 12239, reported to fda on 12/30/2015).

• Brand Name: INNOVA 2100-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer Contact: tammy lee ; 3000 n grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5239660
• MDR Text Key: 32018190
• Report Number: 9611343-2015-00016
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 650369SV4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 9611343-12/30/15-003-C
• Patient Sequence Number: 1